1 15 7 https://www.nal.usda.gov/exhibits/speccoll/files/original/f5622d5af3de69e74c6be5bafafce4f8.pdf 60c527070e23186ef0e347cf44febd78 PDF Text Text Item D Number °5588 D Not Scanned Houk, Vernon N. Corporate Author Roport/Artldo TitlB RePort of Science Panel to the Agent Orange Working Group with Science Panel Review of Proposed Protocol Design for Veterans Administration Epidemiology Study, dated March 5, 1982 Journal/Book Title Year 1982 Month/Day Color Number of Images D 6 Doscripton Notes Tuesday, March 19, 2002 Page 5588 of 5611 �REPORT OF SCIENCE PANEL TO THE AGENT ORANGE WORKING GROUP There have been several meetings of the Science Panel since my last report. Protocol Review The Science Panel completed its review of the National Cancer Institute (NCI) "A Case-Control Study of Lymphoma and Soft-Tissue Sarcoma: Association with Herbicide Exposures." It was agreed that the individual reviews will be returned to NCI. In general, the Science Panel was supportive of the proposal, and several agencies offered to help provide specific information. We further noted that this study should be complementary to the NIOSH proposed case control study on soft tissue sarcoma. The two studies are not exclusive of one another. Status of Fat Biopsies The Chairman of the Fat Biopsy Subcommittee reported that the Subcommittee is developing a report to the Science Panel on fat biopsies for dioxins that will include information on (a) what is currently known and the current status, (b) when we would recommend it be done and under what circumstances, and (c) its limitations. It is anticipated that this report will be available in the near future. Assessment of Agent Orange Health Hazards in the Population in Vietnam Recent press reports of a group returning from Vietnam indicated that the Government of Vietnam would welcome assessment of the health risks in the Vietnam population by American scientists. There is concern about the status of the records and the availability of those records in Vietnam. Dr. T. E. Woodward, VA distinguished physician, reported that he found the records to be useful. There was general agreement that a study would be difficult to do and difficult to interpret. We believe that assessing exposure would be virtually impossible. Public Information A member of the Science Panel expressed concern that the public does not have information available to counter some of the claims of adverse health effects which are not yet proven. There was general discussion of this topic. Most members feel that there is insufficient data to make firm statements on these issues at the moment. The Veterans Administration Mortality Study The Subcommittee reviewing the proposed Veterans Administration Mortality Study has reached consensus on recommendations to be made to the Veterans Administration. These will be forthcoming to the Chair, Agent Orange Working Group within the next 2 weeks. �Review of the Veterans Administration Epidemiology Study The Science Panel concluded its review of the Veterans Administration Epidemiology Study proposed protocol from the University of California at Los Angeles. A detailed review has been submitted to the Chair, Agent Orange Working Group for transmittal to the Veterans Administration. In summary, on the basis of the present document, the panel believes it is possible to begin the pilot phase of the study. The selection of the cohort for the Pilot Study should immediately proceed as well as the quality control and quality assurance procedures, the redesign of the questionnaire, and the determination of comparability and interpretation of some of the proposed instruments, such as nerve conduction studies, spirometry, etc., between examining centers. Finally, we believe that major progress has been made in the past several months and that it is now possible to do the Veterans Administration Epidemiology Study, looking not only at Vietnam exposure but exposure to Agent Orange. We view as the only remaining factors that will prevent the successful completion of this study to be the degree of participation among the selected veterans and the nonavailability of necessary resources. Vernon N. Houk, M.D. Chair, Science Panel Agent Orange Working Group 3/5/82 �AGENT ORANGE WORKING GROUP SCIENCE PANEL REVIEW OF PROPOSED PROTOCOL DESIGN FOR VETERANS ADMINISTRATION EPIDEMIOLOGY STUDY By School of Public Health University of California at Los Angeles The following represents a consensus of the reviewers of the proposed protocol design. All reviewers were present except one and his detailed comments were made available to the other members. The individual comments are enclosed (Tab B). Overall Design We agree that the historical cohort approach is the appropriate one. One member suggested more consideration be given to a case control approach but all other reviewers felt this is not possible because there is no clear cut definition of a "case." We also agree with the approach to try to make it as compatible as possible with other large studies such as the Ranch Hand and the Australian Study. COHORT Selection The panel unanimously agrees that the Department of Defense (DOD) should select the cohorts in accordance with Dr. Bricker's cohort selection paper (Tab A). This will provide, we believe, for elimination of as much misclassification as is possible from the existing or potentially reconstructable records. We believe it is absolutely essential that the identification and assignment of these individuals to the different cohorts not be available to the participants or to the investigators until initial analysis of the data is completed. The Science Panel will oversee this cohort selection process. The study investigators must be aware of the method used to select the cohorts but must not be aware of the individuals placed in each group. Criteria For Each Group We recommend that groups be composed of high probability of exposed Vietnam veterans, high probability of nonexposed Vietnam veterans, and a non-Southeast Asia veterans group. Some felt that it would be desirable to include a Vietnam veterans group exposed midway between the first and second groups in order to make an assessment of dose response. The consensus is that though this may be desirable, the inclusion of the fourth group is not essential nor critical to the study. Sample Size We agree that 6,000 in each cohort group is a reasonable figure. As the study progresses and as more information becomes available from other studies, this issue may need to be reexamined. DOD anticipates being able to provide 12,000 in each of the study groups for selection. �Proposed Exclusions from the Cohort Group We believe it is unreasonable to exclude officers and multi-tour Vietnam veterans. These may be separately identified so that appropriate analysis can take place but they should not be excluded from the study. QUESTIONNAIRE Questionnaire to Personal Health Providers of the Individual Veterans Some of the selected veterans may have had multiple health care providers since returning from Vietnam. The panel doubts that many private physicians will fill out detailed questionnaires on their patients and thus wonder about the usefulness of this part of the study. The needed information may have to be obtained in other ways. Individual Veteran Questionnaire The questionnaire as it now exists is unacceptable. It is overly long and uses highly technical terminology which many people including many physicians will not understand. We recommend that careful thought be given to the information that is needed to be gathered, who will administer and where the questionnaire will be administered (telephone, home visits, etc.), and that the questionnaire be redesigned to meet those criteria. The questionnaire should be limited to information that is critical to the study and that will be used in the analysis of the results. Other Instruments The psychological and neuropsychological instruments, all of which were not available for review, should be evaluated and should include only information that will be used in the analysis of the results and presented in a way that would not be offensive to the participants. Physical Examination Data collected from the physical examination should be limited to those items that will be used in the analysis of the study. This does not mean that the physcial examination should not be comprehensive as determined by the examining physician for the particular individual, although items to be used for analysis of results must be collected according to a standard protocol. Laboratory The final decision for the inclusion of laboratory tests for this study should be made after consultation with laboratory scientists to ensure that the best tests for that particular purpose are being used. There are other tests such as chest x-ray, spirometry, nerve conduction tests, etc., that probably have limited usefulness because of the inability to standardize and to intrepret between multiple examining centers. �It is critical that the standardization of laboratory procedures proceed with quality control and quality assurance for collection, transportation, handling, and analysis and that this process be begun immediately in the participating laboratories. Other Areas of Concern For all participants, the panel believes that information should be collected only on those items that are critical to the study, can be standardized, and are such to appropriately interpret between multiple examining centers and laboratories. If the practising physician feels that additional information is necessary for a particular patient to evaluate the health status, it obviously should be done but should not be part of the overall data collection and analysis for the purposes of this study. It is not clear from the proposed protocol the duration of the overall study or time estimates for each individual participant. These should be determined. A possibility that should be considered in regard to future duration is that after completion of the initial examination and analysis, the cohorts names be matched against the National Center for Health Statistics (NCHS) Annual Mortality Index. This would provide nearly all of the necessary followup information and would be more efficient than a mail survey or a hands-on followup of each individual. It should be explicitly stated in the final design that when an abnormality for an individual is found, how that abnormality will be followed, who will follow and treat it, and what system will be set in place to ensure that each individual will receive the necessary medical care. After the initial analysis has been completed and depending upon the results, additional well focused, smaller studies, such as specific case control studies, may be necessary to further define the extent of possible uncovered problems. After the initial analysis has been completed, the method of cohort selection should be made public. While still ensuring individual confidentiality, each participating veteran should be informed of his or her status in the cohort selection process. The panel assumes that the final protocol will address the usual concerns of patient confidentiality, freedom to withdraw from the study, and methods of providing the individual veteran specific medical information of which he or she or his or her physician should be aware for the proper care of the individual veteran. Pilot Study We believe the Pilot Study should include 5 percent of the anticipated study population. We recognize it may not be possible that this be a random sample of the population but that it be clearly stated and understood what that 5 percent represents. The panel unanimously disagrees that the Pilot Study should take place in only one study site but recommends strongly that it be conducted in all examination centers and study sites that will �be used in the overall study. The Pilot Study should be used to determine participation rates and to further refine the instruments to be used in this study. An analysis of the results of the pilot study can be used to make a determination of the possibility of success of the larger study. The results should in no way be interpreted as to effects but only whether it is possible to conduct a scientifically valid overall study. Summary On the basis of the present document, the panel believes it is possible to begin the pilot phase of the study. The selection of the cohort for the Pilot Study should immediately proceed as well as the quality control and quality assurance procedures, the redesign of the questionnaire, and the determination of comparability and interpretation of some of the proposed instruments, such as nerve conduction studies, spirometry, etc., between examining centers. Finally, we believe that major progress has been made in the past several months and that it is now possible to do the Veterans Administration Epidemiology Study, looking not only at Vietnam exposure but exposure to Agent Orange. We view as the only remaining factors that will prevent the successful completion of this study to be the degree of participation among the selected veterans and the nonavailability of necessary resources. � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 198 Folder The folder containing the original item. 5588 Series The series number of the original item. Series VIII Subseries II Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Creator An entity primarily responsible for making the resource Houk, Vernon N. Date A point or period of time associated with an event in the lifecycle of the resource 1982 Title A name given to the resource Report of Science Panel to the Agent Orange Working Group with Science Panel Review of Proposed Protocol Design for Veterans Administration Epidemiology Study, dated March 5, 1982 ao_seriesVIII https://www.nal.usda.gov/exhibits/speccoll/files/original/4dde28725097f18152b8d6f2e8cba29b.pdf 9e07b829ff30f8cdbab8357f68d5fea9 PDF Text Text item D Number 05534 Author G Not Scanned Houk, Vernon N. Corporate Author Report/Article Tltlfl Memorandum from Chair, Science Panel, Agent Orange Working Group, to Members, Science Panel, Agent Orange Working Group, Subject: Minutes of January 27 Meeting, dated February 2, 1982 Journal/Book Title Year 1982 Month/Day Color Number of Images D 3 Tuesday, March 19, 2002 Page 5584 of 5611 �DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Centers for Disease Control Memorandum Date From February 2, 1982 Chair, Science Panel Agent Orange Working Group Subject Science Panel Meeting Minutes To Members, Science Panel Attached are the minutes of the last Science Panel meeting. Please return your comments to me by February 16 so that I may finalize the comments. Vernon N. Houk, M.D. Attachment �MINUTES OF THE SCIENCE PANEL AGENT ORANGE WORKING GROUP The Science Panel met on January 27, 1982. is appended. ' A list of the attendees (Tab A) ' Status of Fat Biopsies i The Chairman of the Fat Biopsy Subcommittee reported that the Subcommittee is developing a report to the Science Panel on fat biopsies for dioxins that will include information on (a) what is currently known and the current status, (b) when we would recommend it be done and under what circumstances, and (c) its limitations. It is anticipated that this report will be available within 6 weeks. Protocol Review The Science Panel completed its review of the National Cancer Institute (NCI) "A Case-Control Study of Lymphoma and Soft-Tissue Sarcoma: Association with Herbicide Exposures." It was agreed that the individual reviews will be returned to NCI. In general, the Science Panel was supportive of the proposal, and several agencies offered to help provide specific information. We further noted that this study should be complementary to the NIOSH proposed case control study on soft tissue sarcoma. The two studies are not exclusive of one another. Veterans Administration Mortality Study The Chairman of the Subcommittee reviewing the VA Mortality Study reported to the Science Panel. There was "considerable discussion about the proposed study's ability to answer the question. Most but not all members feel that a proportional mortality study of all of the death certificates may be desired. Though the BIRLS tapes data are generally considered to be accurate and complete, there is question about the accuracy and completeness of the proposed Department of Defense (DOD) tapes that are going to be used for matching data. The Science Panel requested the subcommittee continue its work and report within 6 weeks on various options and resource requirements for each option to address this issue. The VA provided information (Tab B) on the numbers of individuals involved for the proposal as it was submitted. Agent Orange Troop Exposure and Non-Exposure Cohort Selection Concept Paper The DOD'provided further details (Tab C). It is agreed that it is possible to develop cohorts of exposed and nonexposed units. It is anticipated that the Science Panel will recommend to the Agent Orange Working Group that a letter detailing the proposal and requesting that it be completed be sent from Secretary Schweiker to Secretary Weinberger. In addition, a review of the disposal of herbicide waste and a trip report by the DOD assessing the herbicide usage in Vietnam were made available to the Science Panel (Tab D). �Assessment of Agent Orange Health Hazards Among the Vietnam Population Recent press reports of a group returning from Vietnam indicated that the Government of Vietnam would welcome assessment of the health risks in the Vietnam population by American scientists. There is concern about the status : of the records and the availability of those records in Vietnam. Dr. T. E. Woodward, VA distinguished physician, reported that he found the records to be useful. There was general agreement that a study would be difficult to do and difficult to interpret. The members of the Science Panel were asked to provide written comments to the Chair within 2 weeks. A concensus document will then be developed for transmission to the Agent Orange Working Group. Health Problems of U.S. Military Veterans and Possible Exposure to Phenoxy Acid Herbicides in Vietnam: Partial Coding and Statistical Analysis of the Citizen Soldier Health Questionnaire (CSHQ) Dr. John Moore made available to the Science Panel the final report to the National Toxicology Program of the statistical analysis by Dr. James H. Dwyer and Mr. Robert Smith of the New York State University at Stony Brook (Tab E). Public Information A member of the Science Panel expressed concern that the public does not have information available to counter some of the claims of adverse health effects which are not yet proven. There was general discussion of this topic. Most members feel that there is insufficient data to make firm statements on these issues at the moment. It was* noted that the Scientific Panel under the direction of Dr. John Moore prepared such a document that was released at the public meeting of the Agent Orange Working Group held in September 1980. A copy of that document will be reviewed to determine if any additional information is available. The members of the Science Panel were asked to communicate their thoughts in writing to the Chair, and this will be discussed further. Vernon N. Houk, M.D. Chair, Science Panel Agent Orange Working Group � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 198 Folder The folder containing the original item. 5584 Series The series number of the original item. Series VIII Subseries II Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Creator An entity primarily responsible for making the resource Houk, Vernon N. Date A point or period of time associated with an event in the lifecycle of the resource 1982 Title A name given to the resource Memorandum from Chair, Science Panel, Agent Orange Working Group, to Members, Science Panel, Agent Orange Working Group, Subject: Minutes of January 27 Meeting, dated February 2, 1982 ao_seriesVIII https://www.nal.usda.gov/exhibits/speccoll/files/original/e913fe547760a74923fb7ac1b363e1b6.pdf ca1d9b9c6b9980ae26899235309aacd5 PDF Text Text Rom D Number osssi Author D NotSBannBn- Houk, Vernon N. Corporate Author RODOrt/ArtlGlOTItlO Memorandum from Chair, Science Panel, Agent Orange Working Group, to Members, Science Panel, Agent Orange Working Group, Subject: Minutes of December 14 Meeting and Draft Memorandum to Chair, AOWG, dated December 17, 1981 Journal/Book Title Year 1981 Month/Day Color Number of Images D ° Descrlptoo Notes Tuesday, March 19, 2002 Page 5581 of 5611 �DEPARTMENT OF HEALTH & HUMAN SERVICES Date Public Health Service Centers for Disease Control .December 17, 1981 (404) 452-4111 FTS 236-4111 From Chair, Science Panel Agent Orange Working Group Subject Minutes of December 14 Meeting and Draft Memorandum to Chair, AOWG To Members, Science Panel Agent Orange Working Group Attached are the minutes, of the last meeting and a memorandum to the Chair, Agent Orange Working Group concerning the Wisconsin Mapping proposal. Please provide your feedback by January 14. The next meeting will be January 14, 1982, 9 a.m., in Room 729G of the Hubert Humphrey Building, Washington, DC. ernon N. Houk, M.D. 2 Attachments �DRAFT MINUTES OF THE SCIENCE PANEL AGENT ORANGE WORKING GROUP The Science Panel met on December 14. appended. A list of the attendees (Tab A) is The Science Panel notes with pleasure that Dr. Peter Greenwald, Director, Division of Resource Centers and Community Activities, National Cancer Institute, has been invited to membership on the Science Panel. Documents Distributed.to the Members; Texas State Veterans Agent Orange Act, H. B. No. 2129 (Tab B). Associated Press release on the State of Wisconsin veterans populations with alleged health effects of Agent Orange (Tab C). Jennifer A, Hanify, et al, "Aerial Spraying of 2,4,5-T and Human Birth Malformations: An Epidemiological Investigation," Science, Vol. 212, 17 April 1981 (Tab D). Kingsley M. Stevens, "Agent Orange Toxicity: Human Toxicology (1981), Vol. 1 (Tab E). A Quantitative Perspective," "The Public Health Conference on Records and Statistics, The People's Health: Facts, Figures, and the Future," DHEW Publication No. (PHS) 79-1214 (Tab F). Protocols Received Dr. Shelia K. Hoar, Environmental Epidemiology Branch, National Cancer Institute, submitted a research protocol, "A Case-Control Study of Lymphoma and Soft-Tissue Sarcoma: Association with Herbicide Exposures," to the Science Panel for review (Tab G). The Chair asked for individual comments by January 15, 1982. These comments will be consolidated and returned to Dr. Hoar. Agent Orange Troop Exposure and Non-Exposure Cohort Selection Concept Paper The Department of Defense transmitted on December 4, 1981, a proposed Agent Orange troop exposure and nonexposure cohort selection concept paper (Tab H). From this concept, DOD indicated that it would be possible to identify groups of personnel down to the platoon level who have had certain characteristics of exposure to Agent Orange. These would include being within a kilometer within 7 days of fixed wing herbicide spraying, stationed in base camps with perimeter spraying, being associated with the so-called "aborted missions," etc. Other groups could be identified who would not have any of the above characteristics. An additional group could be identified from serving in the same time frame in southern continental United States bases where no herbicides were used. These groups could then be the basis of the VA Morbidity Study. The DOD was aksed to provide and report more specific details in the next meeting on January 14, 1982, �Wisconsin Proposal for HERBS Tapes Data for Mapping At a previous meeting the proposal from Wisconsin to the Veterans Administration to develop detailed, accurate, and reliable map series or atlas based on the HERBS tape data depicting the dates and locations of herbicide spraying missions conducted in the Republic of South Vietnam had been distributed and comments requested. In general, it was felt that to be useful, the maps should be accurate and reliable. Because they would not include information on base perimeter spraying and the so called "aborted missions," it was felt they would not be scientifically useful since they would be incomplete. Using the data on the HERBS tapes alone would require mapping on a 1:50,000 scale and would require approximately 1500 maps. The Chair will develop recommendations to the Agent Orange Working Group that contains the consensus of the entire Science Panel to be delivered to the Agent Orange Working Group at its next meeting in January. Veterans Administration MortalityJ5tudy_ The preliminary protocol for the Vietnam veterans study was again discussed. Serious concerns were raised the accuracy of the DOD computerized records that are being proposed for this study. The Science Panel members had divergent views on whether the study should be of the total Vietnam veterans death records or whether sample techniques could be used. A subcommittee was formed to review this matter and make recommendations to the Science Panel at the next meeting on January 14. The subcommittee to be chaired by Dr. Kimbrough also includes Drs. Greenwald, Keller, Brown, and Shepard. Dr. Greenwald also discussed the Upstate New York Mortality Study. Vernon N. Houk, M.D. Chair, Science Panel Agent Orange Working Group �DRAFT 12/17/81 FROM: Chair, Science Panel Agent Orange Working Group SUBJECT: TO: Wisconsin Proposal for HERBS Tapes Data for Mapping Mr. James Stockdale Chair, Agent Orange Working Group At a previous meeting the proposal from Wisconsin to the Veterans Administration to develop a detailed, accurate, and reliable map series or atlas based on the HERBS tape data depicting the dates and locations of herbicide spraying missions conducted in the Republic of South Vietnam had been distributed and comments requested (Tab A). The following is a consensus recommendation to you from the Science Panel. If you concur, we recommend it be forwarded to the Veterans Administration. While the Science Panel agrees in principle that detailed maps could be made available to others for the purpose of determining exposure to Agent Orange in Vietnam, we have serious reservation because it is unlikely that they would be sufficiently accurate to determine proximity to exposure in all instances. A mapping of only the HERBS tapes locations would require from 1,200 to 2,000 maps on a minimum scale of 1:50,000. There are sufficient errors on the HERBS tapes that would not allow exact locations of all fixed wing spraying missions. In addition, very few of probably hundreds of helicopter spraying missions around fire bases, along roads, lines of communications, and along rivers are documented in the HERBS tapes. �Similarly, perimeter spraying from trucks and by backpack sprayers could not be adequately documented. While we agree in principle that we should make everything available, it is our consensus that if. the maps are inaccurate and so voluminous as not to be useable that they in fact will do a disservice. One can argue that detailing the limitations of the maps is an approach to being able to provide them. It is our experience that those caveats are not always recognized and the maps are used as "gospel" without full understanding of their limitations. This would also be costly and would not successfully compete for the scarce resource dollars available for health studies. Thus, there are public relations reasons for approving this proposal but scientific reasons for not doing so. and usefulness. Those scientific reasons are accuracy The Science Panel would recommend at this time that the Veterans Administration be advised not: to financially support such a project. Vernon N. Houk, M.D. � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 198 Folder The folder containing the original item. 5581 Series The series number of the original item. Series VIII Subseries II Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Creator An entity primarily responsible for making the resource Houk, Vernon N. Date A point or period of time associated with an event in the lifecycle of the resource 1981 Title A name given to the resource Memorandum from Chair, Science Panel, Agent Orange Working Group, to Members, Science Panel, Agent Orange Working Group, Subject: Minutes of December 14 Meeting and Draft Memorandum to Chair, AOWG, dated December 17, 1981 ao_seriesVIII https://www.nal.usda.gov/exhibits/speccoll/files/original/2e214e0fb913ea087478b53981ddcf2c.pdf 0ed8b7943bc8d2e2d011006c9bcef391 PDF Text Text ItemDNumbBr "m Author Houk, Vernon N. CorDOratB Author Department of Health and Human Services RepOrt/ArtiClB TItiB The D Perception of Risk Journal/Book Title Year 1984 Month/Day October 15 Color D Number of Images 15 DBSCriptOn NOtBS National Conference on Environmental Public Health, Ramada Inn Central, Atlanta, Georgia Wednesday, January 16, 2002 Page 4174 of 4258 �DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Centers for Disease Control Atlanta GA 30333 FOR RELEASE ONLY UPON DELIVERY THE PERCEPTION OF RISK Vecnon N. Houk. M.D. Director Center for Environmental Health Centers for Disease Control and Assistant Administrator Agency for Toxic Substances and Disease Registry Public Health Service Department of Health and Human Services Atlanta, Georgia 30333 National Conference on Environmental Public Health Ramada Inn Central Atlanta, Georgia October 15, 1984 �INTRODUCTION Risk may be defined in various ways. Risk can be considered the possibility of loss, injury, disadvantage, destruction, contingency, or danger. equivalent to threat. Risk can also be considered to be A risk can be considered to be someone or something that creates or suggests a hazard or an adverse chance, a dangerous element or factor. In recent years, risk assessments and risk analyses have become increasingly sophisticated. This is an extremely difficult area which is not based on objective science but primarily on judgment and our concepts of risk. The most important issue is how we perceive risks and what we, as a society, feel are acceptable. The United States has emerged from an era where the main concern of society was survival to an era where our main preoccupation seems to rest on extending longevity and improving the quality of life. This philosophy is in conflict with our increasing suicide rate among young people; our continued abuse of recreational drugs, alcohol consumption, and cigarette smoking; and our motor vehicle injury and death rates. �What are the risks or hazards that we are concerned about, and how do we perceive them? In order to analyze differences in our perception of risk, it first needs to be determined what the risks are that we encounter in our daily lives, what the frequency of injury from such risk is. and finally, how we consider and deal with these risks. These various risks are listed in tables which I will now show (Numbers 1 - 5 ) . ESTIMATED FATALITIES PER YEAR IN THE UNITED STATES (TAKEN FROM 1979 VITAL STATISTICS) 1. TOTAL DEATH/YEAR 1.914.000 2. MAJOR CARDIOVASCULAR DISEASES 958.000 3. MALIGNANT NEOPLASMS 403.000 4. HOMICIDE 52.000 5. SUICIDE 27.000 6. MOTOR VEHICLE FATALITIES 50.000 7. OTHER CAUSES 824.000 �—#2 WHAT ARE THE CHANCES (BASED ON DEATH RATES)? 1. A 1 OUT OF 2 CHANCE OF DYING FROM A MAJOR CARDIOVASCULAR DISEASE. 2. A 1 OUT OF 4 OR 5 CHANCE OF DYING FROM CANCER. 3. A 1 OUT OF 40 CHANCE OF GETTING MURDERED. 4. A 1 OUT OF 40 CHANCE OF GETTING KILLED IN AN AUTOMOBILE CRASH. 5. A 1 OUT OF 70 CHANCE OF COMMITTING SUICIDE. —#3 WHAT ARE THE CHANCES PER YEAR FOR THE U.S. POPULATION (220 MILLION)? 0.9% (9/1.000) OF THE POPULATION DIE OF ALL CAUSES. 0.44% (4/1.000) DIE OF MAJOR CARDIOVASCULAR DISEASES. 0.18% (2/1.000) DIE OF CANCER. 0.02% (2.4/10.000) DIE OF HOMICIDE. 0.012% (1.2/10.000) DIE AS THE RESULT OF SUICIDE. 0.02% (2.2/10.000) DIE AS THE RESULT OF MOTOR VEHICLE CRASHES. �—#4 MOTOR VEHICLES - HAZARDS AND PREVENTIVE MEASURES * ONE INJURY IN 50 - 60 PEOPLE PER YEAR. * 50.000 FATALITIES PER YEAR. * ONLY 11% OF CAR OCCUPANTS WEAR SEAT BELTS. * IF 75% OF THE POPULATION WORE SEAT BELTS. 14,000 LIVES PER YEAR COULD BE SAVED. * AIRBAGS WOULD RESULT IN A 50% REDUCTION IN FATALITIES, SAVING 25.000 LIVES PER YEAR. --#5 FACTS ABOUT CIGARETTE SMOKING 1. THE SMOKE FROM rr^r CIGARETTE/DAY IS A VIRTUALLY SAFE DOSE £* \J \J FOR THE NONSMOKER. 2. TOBACCO'S CONTRIBUTION TO CANCER DEATHS IS ESTIMATED TO BE 30%. 3. CIGARETTE SMOKERS HAVE TOTAL CANCER DEATH RATES TWICE THAT OF NONSMOKERS. 4. HEAVY SMOKERS (MORE THAN 1 PACK A DAY) HAVE A 3-4 TIMES GREATER EXCESS RISK OF CANCER MORTALITY. 5. 85% OF LUNG CANCER CASES ARE DUE TO CIGARETTE SMOKING. 6. LUNG CANCER DEATHS IN THE UNITED STATES INCREASED FROM 18,313 IN 1950 TO 90,828 IN 1977. �Faced with these statistics and with a limited amount of resources, we should examine whether it is necessary to reduce the risk from exposure to suspect carcinogens as it is now suggested by some to a theoretical incidence of one excess cancer in a population of 1,000.000 or one in 100,000. Before we examine that question, I would briefly like to show a slide giving some examples of human carcinogens. (Slide #6) EXAMPLES OF HUMAN CARCINOGENS AND LIFESTYLE FACTORS INFLUENCING THE INCIDENCE OF CANCER (66 - 88% OF CANCERS ARE ENVIRONMENTALLY INDUCED) AFLATOXIN HEMATITE VINYL CHLORIDE 4-AMINOBIPHENYL MUSTARD GAS SOOT AND TARS ARSENIC 2-NAPHTHYLAMINE IONIZING RADIATION ASBESTOS NICKEL ULTRAVIOLET LIGHT BENZENE STILBESTROL TOBACCO CADMIUM OXIDE ALCOHOL DIET CHROMIUM INFECTION As this slide shows, it has been estimated that 66 to 88 percent of all cancers are environmentally induced. To this. I would like to add that there is, to some extent, a �genetic predisposition to the development of cancer. In talking about environmentally induced cancers, this does not mean that these cancers are necessarily induced by synthetic chemicals, that is chemicals made by industry. Lifestyle influences the incidence of cancer more than the exposure to industrial chemicals in "low" concentrations. In addition, smoking is a major cause of cancer, and we should not forget infectious diseases as has recently been demonstrated again very dramatically with the association between Acquired Immunodeficiency Syndrome (AIDS) and Kaposi sarcoma. That lifestyles affect the incidence of cancer is vividly demonstrated by the changing incidence of specific types of cancer in migrating populations. For instance, the incidence of cancer of the stomach in Japanese living in Japan is much higher than in Japanese and their descendants who have immigrated to the United States. In contrast, cancer of the breast in females in Japan is much lower than in Japanese females who have immigrated to Hawaii or to the United States and in their descendants. Both Japan and the United States are highly industrialized countries so that exposure to industrial chemicals in these two populations would most likely be similar; however, the lifestyles and eating habits of these two groups are different. Having examined these facts, let us now look at how risk assessments have been conducted in the last few years in the �United States and what impact they may or may not have on preventing disease. There are a number of industrial chemicals now which have been shown to cause cancer in rodents when rodents are exposed to these chemicals at high doses through gastric lavage. inhalation, or direct skin application. The doses at which these chemicals cause cancer in small groups of rodents varies. This may somehow be related to their degree of toxicity although such relationships have not been examined in detail. Some believe that any amount of a carcinogen, be it ever so small, is capable of inducing cancer in the host if the host receives any dose of such a chemical. Others do not believe this. For example, a very basic concept in toxicology is that for each chemical, there is a dose-response relationship. This was first pointed out by Paracelsus, who stated it in a negative way, "Dosis sola facit, vt venenum non fit," which in English means "The doses alone makes a thing not poison." In other words, reducing the amount given will render the chemical harmless. Commonly, the aphorism is seen as "Dosis sola facit venenum" (Dose alone determines poisoning). In most instances, animal studies have used high dosage levels of the chemical to be tested, and the results of such studies have then been extrapolated to lower untested dosage levels in the animals. With such extrapolations estimates have been made �to determine at which point only one excess cancer in a population of a million or one cancer in population of 100.000 would occur. For these extrapolations, most recently, multistage models have been used, and it has been assumed that the dose-response curve would be more or less linear for all carcinogens. Very few studies have examined the dose-response relationship of carcinogenesis more extensively. conducted with rather high doses. Most studies have been In the United States only one study (Staffa and Mehlman, 1979) was conducted in mice where large numbers of animals (24,000 mice) and several dosage levels of N-2-Fluorenylacetamide 2-FAA (30, 35, 45. 60, 75, 100, and 150 ppm) were employed. The results of this study suggest that perhaps the linear quantal non threshold model is inconsistent with the data. This leaves many questions about "risk assessments" as they are usually modeled. Most likely, at very low dosage levels, antioxidants. such as vitamin E, vitamin C. selenium, and unsaturated fatty acids, would have a protective effect against naturally occurring and man-made carcinogens which cause lipid peroxidation. The contribution to cancer that very low doses of carcinogens would make might well be overriden by lifestyle in general and would be modified by dietary intake of natural antoxidants and thus may not greatly contribute to the risk of cancer or other �chronic diseases. In other instances where the proximate carcinogen is a metabolite, insufficient amount of such a carcinogen may be produced at low dosage levels because of alternate metabolic pathways. Furthermore, repair mechanisms within the cell may have a protective effect against carcinogens at very low dosage levels. For most of the chemicals which have been shown to cause cancer in animals, it is not known whether they actually cause cancer in humans and if they caused cancer at what dosage levels they would do so above background levels. Since this information is not available, extrapolations have been made from rodent populations to human populations. It is not at all clear at this point, whether that is justified. It can be stated that all of the carcinogens that have caused cancer in humans also cause cancer in animals. The reverse is not true. As more carcinogens are identified, it has also become evident that species variations exist. For some chemicals it has been shown that cancer can be produced in mice but not in rats, or cancer can be produced in mice and rats but not in hamsters and subhuman primates. This depends to some extent on differences in metabolism in different species. Many of the parent chemicals are indirect carcinogens and have to be modified in the body to the proximate carcinogen. chemicals may employ several pathways. The metabolism of It is possible, for instance, that at low dosage levels, only one of those pathways �is used, and at high dosage levels, this one pathway is saturated and other pathways come into play. In such situations, the proximate carcinogen may only be formed at high dosage levels. This has never been extensively examined. Furthermore, many chemicals that are classified as carcinogens act as promoters of carcinogenesis. It is not at all clear what their effect would be at very low dosage levels. Thus, from rather insufficient animal data, extrapolationsd are made to establish acceptable levels of risk for human populations. The methods used appear to err on the conservative side, are unsubstantiated by scientific data, and may grossly overestimate risk. In addition to all the uncertainties inherent in such risk assessments, there are also many uncertainties about exposure of populations to chemicals that are in the environment. It has not at all been determined with certainty, whether people receive a dose at all from chemicals that are in soil and what that dose is. We have made some estimates; however, we are still in the process of conducting experiments to determine whether such estimates are justified. Thus, the scientific data base is really not there to make these types of risk assessments and to spend billions of dollars to reduce exposures to such low levels that there would only be a theoretical chance of getting one additional cancer in a million population lifetime exposure. 10 �What needs to be done is to develop the scientific data base so that more meaningful hazard evaluations can be made if humans are exposed to chemicals which are suspect carcinogens. Such hazard evaluations should only be made in the context of preventing disease in the future. They should not be used to establish a "cause-effect" relationship between nonspecific cancer in a given individual and past exposure to low doses of a suspect carcinogen. In individual cases, such cause-effect relationships cannot be established from animal data or from epidemiological studies because of competing factors that come into play at very low dosage levels. The afore does not mean that we should not use "risk assessment" in making decisions; however, we should recognize that the process and the results are not as precise as some would lead us to believe. In doing risk assessments, we emphasize carcinogenesis because of our concern that only a small number of molecules may still cause cancer, while other toxic effects would only occur at higher doses of the chemical. However, such risk assessments are only one part of our armamentarium to estimate potential hazards resulting from exposure to synthesized or naturally occurring chemicals. For example, foodstuffs such as peanut butter and cornmeal may contain aflatoxin at concentrations which according to risk assessment calculations would suggest that we should have an epidemic of liver cancer in the United States, particularly in 11 �the Southeast, where these foods are consumed in large amounts. In reality, human liver cancer in the United states is a rare event and is not increased in the Southeast. Similarly, risks estimated for ethylene dibromide (EDB) according to one calculation would suggest that if water containing 1 ppb (mg/k) of EDB were consumed, this would result in one additional cancer in each population of 1,500. The number of cancers would be even higher if humans were exposed to higher concentrations. It is curious that no data at all suggesting a higher incidence of cancer in populations occupationally exposed exists. Until we do have greater precision using the risk assessment instrument, I would suggest the following approach as reasonable. This approach would divide the process into several factors. 1. Substance hazard evaluation. Is the substance known to be hazardous to animals and humans if human data exist? are the data? What is the mechanism of action and how have the dose response curves been calculated? 2. If the substance is hazardous in animals, what is the theoretical hazard to humans? exposure? What Through what avenues of Or through what mechanism of action? 12 �3. Populations. Are there populations exposed to this material, are the theoretical avenues of exposure possible, and what is the likely degree of exposure? 4. Pilot studies. Is there evidence in the population exposed for continuous exposure? Can such exposure be quantified if the chemical is persistent in humans or can historical data be used to assess this? Based upon the action of the chemicals in those most likely most highly exposed, are there any biologic tests which could be used as an indicator of exposure, or which could be used as an early indicator of adverse health effects? 5. Health studies in the general population. From analysis of appropriately done epidemiologic studies, is there evidence of harm to humans? The public health role is one of prevention. Even in the absence of conclusive evidence that harm to humans has occurred, if the data and evidence from laboratory animal studies is sufficiently strong that harm may occur, then preventing exposure to future populations is a reasonable action. Here the policymaker must address what the potential harm is, what is the potential remedial action, what is the cost of that remedial action, and is it warranted? In determining whether or not it is warranted, it should be borne 13 �in mind there are resource needs for other areas of known beneficial intervention, such as providing prenatal care to mothers-to-be, vaccination of children, improving the nutrition of the general population, and trying to reduce the incidence of homicide, automobile injuries and deaths, and improving our quality of life, which might reduce the suicide rate and the increased use of substances of abuse. REFERENCE: Staffa, J.A. and Mehlman, M.A. 1979. Inovations in cancer risk assessment (EDi study). Pathotox Publishers, Inc., Park Forest. South Illinois. 14 � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 145 Folder The folder containing the original item. 4174 Series The series number of the original item. Series VI Subseries III Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Creator An entity primarily responsible for making the resource Houk, Vernon N. Description An account of the resource <strong>Corporate Author: </strong>Department of Health and Human Services Date A point or period of time associated with an event in the lifecycle of the resource October 15 1984 Title A name given to the resource The Perception of Risk https://www.nal.usda.gov/exhibits/speccoll/files/original/6316a5ba0ddfe9564c1117a290c34501.pdf 128c664ded0db086538981d170bfa301 PDF Text Text Item D Number °4164 Author D NotSBannBd Houk, Vernon N. Department of Health and Human Services Report/Article Title The Nature ancl Extent of Scientific Knowledge Journal/Book Title Year 1984 Month/Day March 19 Color Number of Images D 10 American Insurance Association, National Conference on Environmental Injury Compensation, L'Enfant Plaza Hotel, Washington, D.C. Wednesday, January 16, 2002 Page 4164 of 4258 �DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Centers for Disease Control Atlanta GA 30333 FOR RELEASE ONLY UPON DELIVERY THE NATURE AND EXTENT OF SCIENTIFIC KNOWLEDGE Vernon N. Houk, M.D. Director Center for Environmental Health Centers for Disease Control and Assistant Administrator Agency for Toxic Substances and Disease Registry Public Health Service Department of Health and Human Services Atlanta, Georgia 30333 American Insurance Association 'National Conference on Environmental Injury Compensation L1Enfant Plaza Hotel Washington, D.C. March 19, 1984 �There are four myths that abound in this country of ours concerning the potential health problems associated with low dose chronic human exposure to toxic substances in our environment. The myths are that: These problems can be solved by hands on physical examinations of individuals. These problems can be solved by establishing registries of all individuals exposed to hazardous substances. These problems can be solved by the collection of information on the occurrence of diseases in all individuals and the analysis of this voluminous set of data. The scientific process available for studies in humans can give conclusive cause and effect information for an individual's state of health. However, the fact that I recognize these as myths does not mean that I think we cannot reasonably estimate risks from exposure among population groups. Over the past decade, scientists have expended many millions of public and private research dollars in efforts to investigate and understand the complex relationships between human health and exposure to suspected environmental pollutants. The basic tools for this ongoing search are laboratory studies in �animals and epidemiologic studies on humans. Properly done, animal experiments and epidemiologic studies provide a basis for identifying associations between various human health risks and environmental factors, from which public health and environmental protection policies are developed to minimize the risks to current and future populations. Information obtained from the use of these tools—animal toxicology studies, and human epidemiologic investigations—have been misapplied in many instances to diseases in individuals because of a failure of the scientific community to make clear the nature and the limitations of our knowledge about environmentally related health risks. We know there is an imminent threat that this knowledge will be misunderstood and misapplied by those who do not understand the process and want to use it for other purposes; we should be careful to prevent that from happening. A number of diseases exist which are known to be caused by exposure to certain chemical or physical agents. cause. For some diseases, there is no other known Such diseases include asbestosis, radiation sickness, Caisson's disease (decompression illness), and mesothelioma, which is usually caused by asbestos. Most documented frank illnesses caused by chemicals are encountered as (1) occupational ^iseases; (2) effects of mishandling or overexposure to pesticides including germicides; and (3) acute and chronic poisoning episodes (e.g., those involving arsenic, mercury, and lead). In the case of some other illnesses, the chemical-disease link is strong, but not unique. Vinyl chloride causes a rare cancer of the liver, the �Two areas present us with some of the most complex and perplexing scientific problems faced by public health officials today. These are related to the establishment and maintenance of registries of exposed persons and to determining the relationships between exposure to toxic suostances and illnesses. We are attempting to answer the question: What are the increased risks of long-term health effects to persons exposed to hazardous substances? One of the most commonly recommended tools for studying the chronic or long-term effects of exposure is to construct a registry of persons exposed. The persons in the registry can be tested periodically to determine their health status and eventually to determine the cause of their death. Registries cannot be used to give quick conclusive answers to the many questions that people ask about the effects of toxic chemical exposure on their health, the health of their families, or the health of their future children. Even the most active and aggressively pursued studies using registries may require decades to produce meaningful results, it is also true that even when the results of long-term studies are made available, the findings are likely to be hotly debated by scientists who honestly represent different points of view. Other important limitations of registries are infeasibility due to mobility aad privacy and inability to detect conditions with a low attack rate after exposure; even cost must be considered. I point out these inherent limitations in registries to call to your attention the fact that expectations for registries being used as tools to answer in the near future the questions before us today may be unrealistically high. �Some questions are: What measures of exposures should be used to set guidelines for eligibility for inclusion in a registry? To what extent are people willing to participate over the course of a lifetime in active followup registries—a constant, stressful reminder of the fact that they were exposed to a toxic substance? How can we assure that a commitment made today to establish and maintain a registry will be carried through over a period of 10, 20, 30, or 40 years? What level of followup is necessary, scientifically, to provide estimates of risk which can then be used to make sound decisions to manage the risk? Even with these limitations, the Public Health Service has a commitment to the use of registries, where appropriate, to attempt to clarify the link between toxic exposures and adverse health outcomes. We now have a group trying to determine where they are appropriate. We are likewise committed to use the other tools at our disposal —epidemiologic and other—to demonstrate the links where they exist. Many of the epidemiologic tools, unless impeccably used with large enough populations �will yield inconclusive results—neither positive or negative. Unfortunately some people will use inconclusive- results that tend toward the negative as definitely negative results; others claim inconclusive results which tend toward the positive as unequivocally positive results. Both are incorrect. Inconclusive results are simply that, inconclusive! What becomes evident is that many factors influence the development of disease. Since some illnesses, including many cancers, may have latency periods of 20 to 40 years; and since in general, environmental exposure to man-made chemicals has been at relatively low concentrations through a variety of routes—that is, inhalation, ingestion, absorption through the skin—it is presently impossible to determine for the individual precisely what events led to the development of disease. The state of the art in medical science or epidemiology is not such that we can predict with certainty whether a person who has been exposed to chemicals will ultimately develop a particular disease or condition. In most cases then, the conclusion must be drawn that the scientific data base presently available does not permit with certainty a determination of whether exposure has a causal relation to illness occurring in an individual or not. Presently available data do provide sufficient evidence to reduce exposure, and thus possibly prevent disease in the future. There is a reason for this dichotomy between prevention and attribution of cause. The studies which generate information about the chronic low dose toxic effects of chemicals do not permit predictions with full confidence about the health of an individual, but rather only about the health of a population and what the degree of risk a given population will run if it continues to be exposed. �Proper use of the scientific data can lead to important collective public health benefits; use of the data for that purpose would be both responsible and just. On the other hand, to press such data into service to respond to causal effects for an individual's disease holds high potential for misuse of the data. Epidemiologic studies almost never prove cause and effect, though in a few instances reasonable people would accept them as such. For example, in looking at the pathway of exposure and body burden, the association of the reduction of lead used in gasoline production and the reduction of mean blood lead levels in the U.S. population. Over a 4-year period when the lead phasedown in gasoline was occurring, we were conducting a study of blood lead levels in the U.S. population, the Second National Health and Nutrition Examination Survey. Two things, declining blood lead levels in children and lead used in gasoline production, were associated with a correlation coefficient of .95; this could have occurred by chance in less than one in 10,000 times. We removed over 200 possible confounders from the association and the coefficient did not appreciably change. Yet many said this did not demonstrate cause and effect. We agree! The only way in this situation to conclusively prove cause and effect would be to place children in chambers breathing air contaminated with differing lead levels and then measuring the blood lead levels in these children. in a society where this kind of study is not possible 1 purposely expose individuals to hazardous substances. must use only inadvertent exposure where that occurred. Fortunately, we live It is not ethical to Studies done in humans �We will continue to respond to specific incidents of human exposure to toxic or hazardous substances. We will also continue our efforts to measure both the immediate and long-term health effects and to make sound recommendations for the attenuation of the risks. Although the results of our studies may not provide the conclusive answers about health risk which are so much in demand, we have hope that we can demonstrate strong associations, where they exist, between exposure and adverse health outcomes so that reasonable people can take reasonable actions to protect public health and the environment. role as primarily one of prevention. Thus, we see the public health Causal attribution in an individual must be done with great caution and except in rare circumstances cannot be done with certainty when the exposure has indeed been of the low dose, chronic form. � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 145 Folder The folder containing the original item. 4164 Series The series number of the original item. Series VI Subseries III Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Creator An entity primarily responsible for making the resource Houk, Vernon N. Description An account of the resource <strong>Corporate Author: </strong>Department of Health and Human Services Date A point or period of time associated with an event in the lifecycle of the resource March 19 1984 Title A name given to the resource The Nature and Extent of Scientific Knowledge https://www.nal.usda.gov/exhibits/speccoll/files/original/3274dbae34e5de29e5c13b745ec55253.pdf 327ada61ba22f79e99d99f056952068b PDF Text Text Item ID Number 01353 Houk, Vernon N. Corporate Author Report/ArtidO TltlO Memorandum: to Ronald W. Hart, Chairman, Science Panel, Agent Orange Workinh Group (AOWG), from Vernon N. Houk, Assistant Surgeon General, with subject Protocol for Women's Vietnam Veterans Health Study, September 10,1987 Journal/Book Title Year 000 ° Month/Day Color D Number of Images 4 DOSCrlptOn NOtBS Memo discusses concerns that Houk has about the study protocol. He wants the concerns addressed before he will be willing to support conduct of the study. Wednesday, July 11, 2001 Page 1854 of 1870 �DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Centers for Disease Control Memorandum Date .September 10, 1987 From Director Center for Environmental Health and Injury Control Subject Protocol for Women's Vietnam Veterans Health Study To Ronald W. Hart, Ph.D., Chairman, Science Panel Agent Orange Working Group We have reviewed the Women's Vietnam Veterans Health Study Protocol submitted by the Hew England Research Institute, Inc. We have serious concerns about this submission which we have listed below. Until these concerns are adequately addressed, I cannot support conduct of the proposed study. Detailed below are comments on the protocol for the Women's Veteran Health Study. A. Cohor^ Selection 1. Unlike the Vietnam Experience Study, there are differences between the exposed group and the comparison groups in variables other than experience in Vietnam. The presence of such differences increases potential confounding and complicates the analyses. Would it be more satisfactory to limit the scope of the study and the selection of a comparison group (e.g., Limit, the study to army cases and controls) to address the most important hypotheses rather than try to do too much? 2. It is not clear how the VA developed its list of 5000 Army Vietnam veterans—how complete is this list? How complete are the lists of Vietnam veterans in the other services? 3. The sampling frame for the non-Vietnam veterans is not clearly described. 4. How valid is their proposed capture-recapture method as a method of documenting the completeness of the cohorts. 5. What duty stations will women veterans for Cohort B come from? Will the Air Force sample of nurses be large enough for separate comparisons? 6. pages 2-3: What does matched on occupation mean and how will this be possible? 7. Consideration might be given to increasing the number of controls (per case) in the overall study, especially in some of the proposed substudies (e.g., reproductive health). �Page 2 - Ronald W. Hart, Ph.D. B. Reproductive Health 1. The expectation is to find major birth defects in 1% of offspring; a more appropriate expectation is 2-3%. It would be wise to compile a list of specific defects which are to be considered "major" before the study begins. 2. Cases are defined as women who have had a baby with a defect or "two or more spontaneous abortions not clearly attributable to an identified cause." They propose excluding those with an 1 "unequivocal karyotypic abnormality", and those with a uterine abnormality. Exclusion of women who themselves have a tcaryotypic abnormality seems reasonable, but it is unlikely that any will be found in the sample. If the reference implies that aborted fetuses that have a karyotypic abnormality will be excluded, this is not reasonable. An abortion associated with a chromosomal anomaly is a health outcome worth considering in the study. In general, more details are needed on why certain diseases/conditions are being excluded. 3. Spontaneous abortions will be difficult to validate since they are frequently not medically documented. 4. It is stated that women with diethylstilbesterol (DBS) exposure would be kept in the sample. We would suggest exclusion since they are excluding spontaneous abortions associated with uterine abnormality, and DES exposed women have a higher rate of abortion, usually from uterine abnormality. 5. We would suggest matching controls on age at the last abnormal pregnancy, rather than the first. Spontaneous abortion is strongly related to age and a woman's pregnancies may be separated by many years. 6. At the time this study will be done, most women Vietnam veterans will be 40 or more years of age. Therefore the evaluation of prolonged amenorrhea should probably be deleted from the study. 7. A definition of fertility/infertility is needed. C. PsycholoRical/KeuropsychoIoRical TestinR 1. The proposal to use the CDC Vietnam Experience Study (VES) neuropsychological battery is inappropriate. That battery was designed to assess primarily neuropsychological deficits which might be expected from exposure to a toxin (e.g. TCDD). The battery also included some assessment of psychological and neuropsychological problems that might be related to stress. �Page 3 - Ronald W. Hart, Ph.D. This latter component is not included (as far as we can tell) in the present protocol. Since TCDD exposure is unlikely to have been a major problem for most nurses in Vietnam, it would probably be better to give greater emphasis to long-term psychological stress faced by these veterans while in Vietnam. This would mean that the proposed battery should include some measures of stress which have been well validated and accepted in psychological research. ' In addition, greater emphasis should be given to depression, anxiety, and alcohol and drug use, which are possible sequelae of stress. Also, consideration should be given to including the Minnesota Multiphasic Personality Inventory (MMPI), and more of the Diagnostic Interview Schedule (DIS) than just the Post Traumatic Stress Disorder (PTSD) section. 2. Another concern in the psychological area is the testing in the home of the participant. The VES battery was designed to be administered in a standard testing environment by trained technicians under close supervision. Quality control and standardization will be difficult in the proposed setting. 3. The rationale for measurement of TCDD levels in the PTSD substudy needs further clarification/justification. 4. With respect to the psychological area in general, we suggest that advice be sought from experts in psychology/psychiatry to evaluate the proposed psychological test battery. In addition, staffing for the study should include a qualified psychologist or psychiatrist. D. Serum. Dioxin (TCDD) Measurement 1. The whole issue of Agent Orange exposure assessment/TCDD testing becomes questionable now that the results of CDC's Validation Study are known. If TCDD testing is to be done, is a whole unit of blood necessary—if willing to accept some cut-off level (e.g. 20 ppt) less blood may be required. Also, if TCDD testing is to be done, consideration should be given to using a sample of Vietnam and non-Vietnam veterans—based on the results of a sample, a decision could be made about testing other participants. 2. Serum TCDD measurements are to be used as the measure of exposure for both the Reproductive Outcomes Study and the Post Traumatic Stress Disorder Study. Apparently about 550 serum analyses will be needed for these two studies combined. The current proposal does not involve flying the participants to a centralized collection center but rather using local Red Cross Centers on contract. These approximately 550 women will be located all over �Page 4 - Ronald U. Hart, Ph.D. the United States and the Red Cross is not even present in every state, so obtaining the samples solely in this manner will not be possible. A very large number (>100) of Red Cross contracts will be involved to obtain blood on persons near a Red Cross Center under the current plan. The use of at least regional Red Cross Centers would be a marked improvement and the quality of sample acquisition would be significantly higher if only a few (even one) Red Cross Center(s) were used. 3. T|he cost of the serum 2,3,7,8-TCDD measurement should be noted to be $1000 apiece. Currently the protocol states that EHLS is the only lab in the U.S. that can perform the measurements, but clearance for such measurements at EHLS has not been obtained. Similarly, has the American Red Cross been approached as to their willingness to participate in this study? E. Operational and Other Issues 1. The protocol anticipates a fair amount of dependence on both interviews and military records. What are the limitations of these data in terms of the questions addressed (e.g., ascertainment of spontaneous abortions by history)?. 2. The authors do not provide information on how they propose to address the issue of name changes in female veterans and the difficulties this might cause in locating these veterans. 3. The operational aspects of the pediatric examination component are not clearly described. Has the Ranch Hand Study been successful in this area? What end points will be looked at and analyzed? 4. The choice of conditions to be validated might be expanded to include same conditions which have been suggested to be associated with TCDD exposure—e.g. skin conditions (chloracne, hyperpigmentation, etc.), liver disorders including prophyria, peripheral neuropathy, immunologic deficits. 5. Quality control of the physical and routine laboratory examinations must be assured. 6. Has adequate effort been made to insure that the medical records and pathology slides will be reviewed in a blinded manner? 7. What efforts are being made to insure quality assurance and quality control of hormone blood testing? Vernon H. Houk, M.D. Assistant Surgeon General � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 069 Folder The folder containing the original item. 1853 Series The series number of the original item. Series III Subseries III Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Creator An entity primarily responsible for making the resource Houk, Vernon N. Title A name given to the resource Memorandum: to Ronald W. Hart, Chairman, Science Panel, Agent Orange Working Group (AOWG), from Vernon N. Houk, Assistant Surgeon General, with subject Protocol for Women's Vietnam Veterans Health Study, September 10, 1987 Subject The topic of the resource Women Vietnam Veterans Health Study study criticism study protocol dioxin ao_seriesIII https://www.nal.usda.gov/exhibits/speccoll/files/original/0397ef45f6a5749c72a829b6264147b2.pdf e95d695e5c8772b844e37ed1186077ad PDF Text Text Item ID Number 01734 Author Houk, Vernon N. Corporate Author RepOrt/ArtiClB TltlO Memorandum: Review of VA Mortality Study, from Vernon N. Houk to Ronald W. Hart, September 11, 1987 Journal/Book Title Year 000 ° Month/Day Color D Number of unaoos 2 Desorlpton Notes Monday, June 11, 2001 Page 1785 of 1793 �DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Centers for Disease Control Memorandum Date From .September 11, 1987 Director Center for Environmental Health and Injury Control Review of VA Mortality Study Subject To Ronald W. Hart, Ph.D. Director National Center for Toxicological Research i The Veterans Administration (VA) has conducted a proportionate mortality study (PMR) of 24,235 deaths among U.S. Army and U.S. Marine male veterans who served in Vietnam and 26,685 deaths among male veterans of the same two services who did not serve anywhere in Southeast Asia. All deaths were identified from the VA BIRLS file and occurred between July 4, 1965, and March 1, 1982. These deceased veterans had to have served in the military sometime between July 4, 1965, and March 1, 1973. Career and non-career, officers, and enlisted men, as well as reservists, were included. In-service deaths occurring before 1974 and men dying from war-related injuries were excluded. In service deaths after 1973 were included. Within the group of Vietnam veterans, the fraction of all deaths attributable to a particular cause was computed and compared to the corresponding proportion for non-Vietnam veterans. The comparison was done using the proportionate mortality ratio (PMR) technique in which age at death, race, and branch of service were taken into account. There was no adjustment for calendar year of death or rank. Altogether, PMRs were computed for 18 major cause of death groupings and for 23 specific cancer sites. We will address our concerns in data collection, data analysis, and interpretation. Data Collection. Are the BIRLS tapes truly at least 94 percent complete? From the CDC Mortality Study which used multiple sources of mortality we found that BIRLS was less complete. Data Analysis. Why do the authors emphasize only the statistically significant positive findings? Why were not the significant decreases in deaths from genitourinary diseases (Table 3) and the decrease in deaths *. from all cancers for one-tour of duty veterans (Table 5) not discussed? The lack of association between service in be reevaluated in light of the CDC finding in the first 5 years after discharge. CDC discharge rather than year of death. This Vietnam and suicide needs to that they were increased only used the time period since subject was repeatedly brought �Page 2 - Ronald W. Hart, Ph.D. up with the VA prior to completion of their analysis. The CDC study would indicate that grouping by 10 year periods would minimize the effect. The findings for lung cancer and NHL in Marine Vietnam veterans are provocative, although similar observations were not made in other studies of Vietnam veterans. The absence of unusual mortality from soft-tissue cancers is consistent with some previous studies but at variance with others. Because so many statistical tests were done on the data set, these ^apparent findings could be due to chance. It would be helpful to see a more detailed analysis in which mortality from these cancer sites is examined by calendar year in Vietnam, rank, MOS, and principal duty. These additional analyses would help in deciding whether some factor related to the Vietnam experience is responsible for the apparent association. Interpretation. The authors suggest that these were major differences in the findings of previous studies cited, but there are in fact few major differences in the findings. Referenced studies were not critically discussed. There has never been, for example, an association demonstrated between lung cancer and phenoxy herbicides except in the Zack Study (Ref. 29) where 3.6 cases were expected and 6 were found in those exposed to 2,4,5-T. Those authors state that they cannot evaluate trends in lung cancer deaths as they relate to occupation because of "limitation in the data." As noted above, it is not surprising to encounter the small number of statistical departures from expected mortality seen in this study. These could easily have arisen by chance alone. This study, as originally designed, cannot conclusively clarify mortality risks for Vietnam veterans, let alone elucidate possible causative factors within, or outside of, the Vietnam experience. Reasons include lack of a defined population-at-risk, incomplete ascertainment of deaths, and absence of "exposure" data on individual veterans. This PMR study appears to be well executed in mechanics. However, the presentation and discussion of the results do not provide the necessary caution in interpretation and allow the uninitiated to make causal inferences where they do not exist. Vernon N. Houk, M.D. Assistant Surgeon General � Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Title A name given to the resource Alvin L. Young Collection on Agent Orange Description An account of the resource <p style="margin-top: -1em; line-height: 1.2em;">The Alvin L. Young Collection on Agent Orange comprises 120 linear feet and spans the late 1800s to 2005; however, the bulk of the coverage is from the 1960s to the 1980s and there are many undated items. The collection was donated to Special Collections of the National Agricultural Library in 1985 by Dr. Alvin L. Young (1942- ). Dr. Young developed the collection as he conducted extensive research on the military defoliant Agent Orange. The collection is in good condition and includes letters, memoranda, books, reports, press releases, journal and newspaper clippings, field logs and notebooks, newsletters, maps, booklets and pamphlets, photographs, memorabilia, and audiotapes of an interview with Dr. Young.</p> <p>For more about this collection, <a href="/exhibits/speccoll/exhibits/show/alvin-l--young-collection-on-a">view the Agent Orange Exhibit.</a></p> Text A resource consisting primarily of words for reading. Examples include books, letters, dissertations, poems, newspapers, articles, archives of mailing lists. Note that facsimiles or images of texts are still of the genre Text. Box The box containing the original item. 066 Folder The folder containing the original item. 1784 Series The series number of the original item. Series III Subseries III Dublin Core The Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/. Creator An entity primarily responsible for making the resource Houk, Vernon N. Title A name given to the resource Memorandum: Review of VA Mortality Study, from Vernon N. Houk to Ronald W. Hart, September 11, 1987 Subject The topic of the resource VA Mortality Study BIRLS study criticism cancer risk assessment ao_seriesIII